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Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools
Biotech | May 02, 2022

Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools

Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
Drug Approval | May 01, 2022

USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis

The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases


Inmagene receives USFDA's IND clearance for ox40 antagonist
Biotech | May 01, 2022

Inmagene receives USFDA's IND clearance for ox40 antagonist

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers


Zymo invests in Star Array to develop superfast PCR platform
Biotech | April 27, 2022

Zymo invests in Star Array to develop superfast PCR platform

Star Array's focus has been on the development of an automated (cassette-based) nucleic acid purification system coupled with its superfast nucleic acid amplification technology